Label: VANISHING ACNE TREATMENT CREAM CVS HEALTH- benzoyl peroxide 10% cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 4, 2018

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient                                      Purpose
    Benzoyl Peroxide 10%.............................Acne Treatment

  • PURPOSE

  • INDICATIONS & USAGE

    Use for the treatment of acne

  • WARNINGS

    Warnings
    For external use only
    Do not use • if you have very sensitive skin or are sensitive to benzoyl peroxide
    When using this product • skin irritation and dryness are more likely to occur if you use another topical acne
    medication at the same time. If irritation occurs, only use one topical acne medication at a time. • rinse right
    away with water if it gets in eyes • avoid unnecessary sun exposure and use a sunscreen • avoid contact with
    the eyes, lips, and mouth • avoid contact with hair and dyed fabrics, which may be bleached by this product
    • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation
    may be reduced by using the product less frequently or in a lower concentration.
    Stop use and ask a doctor if skin irritation becomes severe

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Directions • cleanse the skin thoroughly before applying medication • cover the entire affected area
    with a thin layer one to three times a day • because excessive drying of the skin may occur, start with one
    application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. If
    bothersome dryness or peeling occurs, reduce application to once a day or every other day. • if going
    outside, use a sunscreen. Allow product to dry, then follow direction in the sunscreen labeling. If
    sensitivity develops, discontinue use of both products and consult a doctor.

  • OTHER SAFETY INFORMATION

    Other information • keep tightly closed • keep away from heat

  • INACTIVE INGREDIENT

    Inactive ingredients Aluminum Hydroxide, Bentonite, Carbomer, Glyceryl Stearate, Isopropyl
    Myristate, PEG-12, Potassium Hydroxide, Potassium Sorbate, Propylene Glycol, Water.

  • Questions? 855-543-3784

  • PRINCIPAL DISPLAY PANEL

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    VANISHING ACNE TREATMENT CREAM  CVS HEALTH
    benzoyl peroxide 10% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-671
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzoyl Peroxide (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) Benzoyl Peroxide10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
    Bentonite (UNII: A3N5ZCN45C)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    Potassium Hydroxide (UNII: WZH3C48M4T)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-671-0128 g in 1 TUBE; Type 0: Not a Combination Product08/15/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D08/15/2018
    Labeler - CVS (062312574)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(69842-671) , label(69842-671)